MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PAL 2123#BE-HLS CANNULA 21F AL

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when further information becomes available.

Event Description

It was reported that there was a blood leakage due to crack on the hls cannulae.No further information has been received.No actual harm or death was reported.Complaint #(b)(4).

Manufacturer Narrative

It was reported that there was a blood leakage due to crack on connector.Hls cannula had been used for 7 days on patient.No harm to any person has been reported.Customer could not stop leakage and changed the product.The product was investigated in getinge laboratory on 2022-03-10.Visual control was performed and some residues of adhesive tape and blood were found in the area of the connector.Air pressure filled test under water was performed.At a pressure of around 0.3 bar a leakage was detected at the luer of the cannula due to crack.Based on the test results, failure could be confirmed.The production history record (dhr) of the affected be-hls cannula 21f al with lot# 3000147833 was reviewed on 2022-03-21.According to the dhr results, the product be-hls cannula 21f al passed the defined manufacturing and final release specifications.It was reported that the sample was cleaned with alkazym by customer for decontamination.The sample investigation shows that there were a lot of damages on the connector.However, there is no information that alkazym could cause such damages on polycarbonate (the material of connector).Additionally, it was stated within this complaint that hls cannula was used for 7 days on patient with an ecmo set except maquet.According to instruction for use (ifu) of hls cannula: "in the event that the coated hls cannulae are not used in combination with the sets pls set, pls set plus or hls set advanced from maquet cardiopulmonary, the maximum duration of use for the hls cannulae is 6 hours."however, as initially stated the hls cannula was used for 7 days with an ecmo set from different brand.The evaluation of getinge research & development, contrarily, cannot confirm that cause of the crack is linked to the use of the hls cannula with a different ecmo set for longer than stated in the ifu.Based on the received information and investigation results, the reported failure could be linked to the risk assessment and control hls cannulae (dms#1992719, v04) and the most probable cause could be: -user error: lack of attention on device handling; -user error: lack of information on tube connection; -user error: mechanical damage of cannula during fixation due to lack of attention / lack of information.The getinge sales and service unit will be informed about the investigation results to communicate to the customer, and to inform the customer about the ifu information on hls cannula maximum duration of use.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

(b)(4).

• Brand Name: CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 13091902
• MDR Text Key: 282805103
• Report Number: 8010762-2021-00676
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: BE-PAL 2123#BE-HLS CANNULA 21F AL
• Device Catalogue Number: 701047288
• Device Lot Number: 3000147833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1